ANZCTR search results

Despite the promise of whole of systems community-based obesity prevention interventions to improve the health of the population, there has been challenges with the implementation of such initiatives. Such interventions are inherently complex in nature and present unique implementation challenges that require targeted implementation support. This pilot RCT and feasibility study therefore seeks to assess the i) potential usefulness of strategies to support the implementation of evidence-based and locally appropriate solutions generated via systems mapping approaches in rural or regional communities, and to pilot certain elements of the research to inform the conduct of a fully powered RCT . Implementations team in the intervention arm will receive support to prioritise local and evidence-based actions for implementation, use a systems mapping lens to identify key determinants to implementation and generate suitable solutions and support from an experienced facilitators to troubleshoot any implementation challenges for approximately 6 months. The key outcomes of the study include describing potential changes in implementation fidelity and intention, as well as describing the process of recruiting, data collection and any adaptations to delivery protocol. This study address an important gap in the literature, and provide important data to inform the development of future studies supporting community-based implementation of obesity prevention programs.

The pilot randomised controlled trial aims to test the feasibility of a large trial. The trial will evaluate the effectiveness of virtual reality headset in managing emergency department (ED) patients' painful procedure related anxiety. Clinical outcomes includes anxiety, stress, pain, procedural sedation and anaesethics, procedure time, ED length of stay, patient and staff satisfaction and acceptability, and adverse events.

This study aims to assess how a new test (ArteraAI) that uses artificial intelligence to analyse prostate tumour samples to predict patient outcomes and suitable treatment options impacts the treatment recommendations that doctors make for their patients with prostate cancer. Who is it for? You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with a localised intermediate risk prostate cancer (one or more tumours) and you are scheduled to undergo initial curative radiotherapy treatment for your cancer. Study details All participants who choose to enrol in this study will have a sample of their prostate cancer assessed using a new test, ArteraAI, that uses artificial intelligence and a specialised computer algorithm to analyse the characteristics of their specific cancer. The ArteraAI test will use previously collected tumour samples so that participants will not need to provide further tissue for this study. Depending upon the results of the ArteraAI test, participants may have their cancer treatment plan changed to include or stop use of ADT (testosterone blocking drugs). A subgroup of participants will also be followed up at five years after they have undergone the ArteraAI test to check their Prostate Specific Antigen (PSA) levels noted in their medical records . PSA is collected as part of normal care follow-up for prostate cancer, therefore participants won’t need an additional blood test for this. It is hoped this research will determine whether use of the ArteraAI test helps doctors to make more informed treatment recommendations for patients with prostate cancer. If the ArteraAI test is found to be useful and the costs associated are not prohibitive to publicly-funded medical care, use of the test may be expanded to a greater number of cancer treatment clinics to assist a greater number of patients with prostate cancer.

The aim of the proposed research is to investigate the feasibility of conducting a clinical trial of relaxation practice for outcomes of subclinical anxiety, stress, and worry in a healthy adult population via a smaller feasibility trial. A secondary aim is to determine the preliminary efficacy of two different relaxation practices when compared to each other practice across these outcomes. Lastly, the aim of the proposed research is to further understand the neurological mechanisms involved in relaxation practice and whether they may be associated with any clinical outcomes found.

To assess the clinical utility of using a non-invasive haemodynamic monitoring device (the Clearsight TM system) in the cardiac assessment of patients undergoing CRRT and IHD To evaluate the feasibility of using the Clearsight TM system on patients that are currently on CRRT To evaluate the feasibility of using the Clearsight TM system on patients that are currently on IHD To evaluate the haemodynamic changes that occur during a CRRT session and how are these changes correlated to the clinical status of the patient To evaluate the haemodynamic changes that occur during an IHD session and how are these changes correlated to the clinical status of the patient Patients rercruited would have already been receiving IHD or CRRT and were then approached to enter this study. Patients would not have their IHD or CRRT intervention altered in anyway. The ClearSight cardiac output monitoring device is a small pressure cuff that is applied the the middle phalanx of either the 2nd, 3rd or 4th finger. This allows for continuous monitoring of cardiac output

Congenital cytomegalovirus (CMV) infection can lead to lifelong disabilities in babies if passed from the mother during pregnancy. It is the leading infectious cause of newborn disability in Australia and can result in conditions such as deafness, intellectual disability, and cerebral palsy. To prevent the morbidity and mortality associated with CMV, it is important for pregnant women to receive appropriate antenatal care and support. This study aims to assess the feasibility and acceptability of routine serological screening for maternal primary CMV infection early in pregnancy. Pregnant women who test negative for CMV IgG before 10 weeks of gestation will be eligible to participate. Participation involves providing a blood sample between 10 weeks 0 days and 13 weeks and 6 days of gestation for repeated testing of CMV infection. Additionally, participants will complete three questionnaires during the study period to evaluate the effectiveness of the CMV screening protocol, including measures of anxiety, decisional conflict, and decisional regret. If the serology results are negative (indicating no infection) at 10-14 weeks of gestation, the woman will be informed over the phone, and the results will be recorded in her medical records. If a woman is found to have been infected by CMV or potentially infected, the results will be disclosed by a maternal fetal medicine specialist, and she will be referred to the Perinatal infectious diseases clinic for counseling and clinical management. The management options offered to these women follow the standard clinical care guidelines for perinatal ID clinics. In case of a confirmed infection during pregnancy (expected in up to 5% of participants), the woman will be offered management options according to usual clinical care. These options may include informing the woman about the possibility of using valaciclovir, prenatal diagnosis through amniocentesis, and, if necessary, fetal MRI. The woman's decision to participate or not in the research will not impact the clinical care provided for CMV infection. At the end of the study, we aim to report the rate of CMV testing uptake during 10-14 weeks of gestation among pregnant women who initially tested negative for CMV IgG at their first antenatal visit with their GP or obstetrician. By analyzing feedback from participants regarding their experience with CMV screening and the clinical management they received for the prevention of congenital CMV infection, we will evaluate the feasibility of implementing a CMV screening program. Furthermore, the study seeks to determine the prevalence of primary CMV infection in the first trimester of pregnancy, document the clinical pathways chosen by participants who were diagnosed with primary CMV infection during this period, and report any psychological consequences associated with antenatal serological screening for CMV infection.

PART A of the study is investigating the safety and efficay of Single ascending dose of BW-20507 in healthy volunteers in 4 dose level cohorts. Who is it for? You may be eligible for PART A this study if you are a healthy adult aged 18 to 60 years old. Study details Participants will receive either each dose of BW-20507 or placebo which will be administered as SC injection(s). The estimated total time on Part A, inclusive of screening and follow-up, for each subject is up to 8 weeks. The duration of screening is 4 weeks. The duration of treatment is a single dose based on the assigned dose level. The duration of follow-up is 4 weeks after study drug administration. It is hoped that this research will help determine the safe and well toerated dose and define the dosing regimen of BW-20507 can be safely given to patients with Chronic HBV Infection.

Part B of the study is investigating the safety and efficacy of multiple ascending doses of BW-20507 in subjects with chronic HBV infection while Part C is a long-term Study to Evaluate the Safety, Tolerability, and Efficacy of BW-20507 in Subjects with Chronic HBV Infection Who is it for? You may be eligible for PART B of the study if you are an adult with chronic Hepatitis B virus infection in the age group between 18-65 years. Subjects who participated in the Part B and completed the Week 32 visit will be automatically enrolled into Part C if his or her HBsAg is = 0.05 IU/ml at Week 32 or following visits in Part B Study details Participants will receive multiple dose of BW-20507 which will be administered as SC injection(s). The estimated total time on Part B, inclusive of screening. treatment and post-treatment follow-up. for each subject. is up to 24 weeks. For subjects consenting to extended follow-up, the estimated total time is up to 52 weeks. Estimated total time for Part C is about 124 weeks. It is hoped that this research will help determine the safe and well tolerated dose and define the dosing regimen of BW-20507 can be safely given to patients with Chronic HBV Infection.

This project will look at the impact of digitalised music therapy during hospital admission for patients living with dementia. Each patient will receive a personalised library of music that they can access throughout their stay via headphones and/or speaker. It is anticipated that patients will experience improvement in behavioural and psychological symptoms associated with dementia (BPSD), with subsequent benefits including a reduction in the use of psychotropic medication, hospital length of stay, caregiver stress and critical incidents.

This primary aim of this study is to examine the effectiveness of Measurement-Based Care (MBC session-by-session measures plus feedback to parents and clinicians) versus Measurement as Usual (MAU) for parents of children aged between 3 and 9 years 11 months of age participating in a 8-10 session BPT, delivered via telehealth. All participating families will complete measures at pre, post and three-month follow-up. Primary outcomes include reduction in severity of children's symptoms of DBDs according to both diagnostic ratings by blind clinicians and parent reports at post-intervention and three- month follow-up. Secondary outcomes include: teacher reports of severity of DBDs; parent satisfaction with treatment; clinician and parent ratings of therapeutic alliance, dysfunctional parenting; parental conflict over parenting; and parental mental health. In addition, clinically significant change in severity of DBDs rated by blind clinicians and parent reports will be calculated and compared across groups. Rates of drop-out from intervention and total time in the program will also be compared across groups. 1. At post-assessment and three-month follow-up, relative to the MAU comparison group, the MBC intervention group will have: a) significantly lower levels of child symptoms of DBDs (diagnostic ratings and parent reports) b) significantly lower levels of teacher ratings of DBDs c) significantly higher parent and clinician ratings of the therapeutic alliance d) significantly higher levels of clinician ratings of child functioning e) significantly lower levels of dysfunctional parenting, inter-parental conflict over parenting, and improved parental well-being. e) significantly higher parent ratings of satisfaction with treatment. 2. Compared to the MAU comparison group, the MBC intervention group will show: a) significantly high levels of clinically significant change in severity of DBDs (for diagnostic ratings and parent reports) at post and three-month follow-up b) significantly lower levels of drop out from the intervention c)significant less time participating in the program overall.